check_circleStudy Completed

Healthy volunteers, Pharmacokinetics, Drug Interaction

Bayer Identifier:

17723

ClinicalTrials.gov Identifier:

NCT02671097

EudraCT Number:

2015-003244-38

EU CT Number:

Not Available
Drug-drug interaction study using rosuvastatin as a breast cancer resistant protein (efflux transporter), organic anion-transporting polypeptide (OATP)1B1, and OATP1B3 (uptake transporters) probe substrate

Trial purpose

Evaluation of the potential perpetrator effect of BAY1841788 (ODM-201) on rosuvastatin pharmacokinetics.
PK of BAY1841788 (ODM-201) after single and repeated administration in male and female subjects.

Key Participants Requirements

Sex

Both

Age

45 - 65 Years
  • - Healthy subject - as determined by medical history, physical examination and all procedures required by this protocol.
    - Age: 45 to 65 years at the screening visit.
    - Race: White.
    - Body mass index (BMI): ≥18.0 and ≤29.9 kg/m*2.
    - Adequate venous access (frequent blood sampling).
    - Ability to understand and follow study-related instructions.
    - Females have to be in postmenopausal state, revealed by: Medical history, if applicable (natural menopause at least 12 months prior to first study drug administration; or surgical menopause by bilateral ovariectomy at least 3 months prior to first study drugadministration) and follicle stimulating hormone (FSH) >40 IU/L at screening examination.
    - Male subjects must agree to use condoms as an effective contraception barrier method during the whole study (starting after informed consent) and for 3 months after the end of treatment with BAY1841788 (ODM-201). In addition, participants must agree to utilize a second reliable method of contraception simultaneously. The
    second method which has to be used by a female partner of childbearing potential can be one of the following methods: diaphragm or cervical cap with spermicide or intra-uterine device or hormone-based contraception.
  • - Medical and surgical history
     -- Subjects with clinically relevant findings in medical history e.g. history or currently existing relevant diseases of vital organs, central nervous system (for example seizures) or other organs (e.g. diabetes mellitus).
     -- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.
     -- Febrile illness within 1 week before the first study drug administration.
     -- A medical history of risk factors for Torsades de Pointes (e.g. family history of Long QT interval in electrocardiogram Syndrome) or other arrhythmias.
    - History of myopathia after treatment with statins.
     -- History of rhabdomyolysis or myopathia.
     -- Medical history of any type of psychiatric disorder, especially mood disorders including medical history with suicidal ideation and/or suicide attempts.
     -- History of thyroid disorders, especially hypothyreosis.
     -- History of respiratory disorder (excluding history of bronchitis or pneumonia).
     -- History of myasthenia.
     -- History of muscle pain or muscle ache, muscle soreness of unknown origin or on frequent occasions although an origin might have been found.
     -- History of any clinically significant hypoglycemia or hyperglycemia.
     -- Relevant hepatic disorders like a history of viral hepatitis, cholestasis, disturbances of bilirubin metabolism, any progressive liver disease.
     -- Relevant renal disorders like recurrent glomerulonephritis, renal injury, and renal insufficiency. However, a history of a single episode of uncomplicated nephrolithiasis will not prevent participation.

Trial summary

Enrollment Goal
30
Trial Dates
February 2016 - August 2016
Phase
Phase 1
Could I Receive a placebo
No
Products
Nubeqa (Darolutamide, BAY1841788)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
CRS Clinical Research Services Berlin GmbHBerlin, 13353, Germany

Primary Outcome

  • Area under the concentration-time curve of Rosuvastatin from time zero to 24 hours (AUC(0-24))
    date_rangeTime Frame:
    Before Rosuvastatin administration, as well as 30 min, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 h after Rosuvastatin administration
    enhanced_encryption
    Safety Issue:
    No
  • Maximum drug concentration (Cmax) in plasma of Rosuvastatin
    date_rangeTime Frame:
    Before Rosuvastatin administration, as well as 30 min, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 h after Rosuvastatin administration
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of subjects with study drug-related treatment-emergent Adverse Events
    date_rangeTime Frame:
    Up to 30 days
    enhanced_encryption
    Safety Issue:
    Yes
  • Area under the concentration-time curve of BAY1841788 from time zero to 24 hours (AUC(0-24)) after single administration
    date_rangeTime Frame:
    Before BAY1841788 administration, as well as 30 min, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 h after BAY1841788 administration, period 2 day 1
    enhanced_encryption
    Safety Issue:
    No
  • Area under the concentration-time curve of BAY1841788 from time zero to 12 hours (AUC(0-12)) after repeated administration
    date_rangeTime Frame:
    Before BAY1841788 administration, as well as 30 min, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 h after BAY1841788 administration, period 2 day 7
    enhanced_encryption
    Safety Issue:
    No
  • Maximum drug concentration (Cmax) in plasma of BAY1841788
    date_rangeTime Frame:
    Before BAY1841788 administration, as well as 30 min, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 h after BAY1841788 administration
    enhanced_encryption
    Safety Issue:
    No

Trial design

A Phase 1, open label, fixed-sequence study to evaluate the effect of BAY1841788 (ODM-201) on drug transporters using rosuvastatin as probe substrate and to assess pharmacokinetics and safety of BAY1841788 in female and male volunteers
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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